SUBLIMAZE (fentanyl citrate) Injection is a potent narcotic analgesic. Each milliliter of solution contains fentanyl citrate equivalent to 50 mcg of fentanyl base, adjusted to pH 4.0 to 7.5 with sodium hydroxide.
SUBLIMAZE (fentanyl citrate) is indicated:
- —for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
- —for use as a narcotic analgesic supplement in general or regional anesthesia.
- —for administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
- —for use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
Media Articles Related to Sublimaze (Fentanyl)
Fentanyl Overdose Deaths Double in a Year
Source: MedicineNet Drug Abuse Specialty [2016.12.21]
Title: Fentanyl Overdose Deaths Double in a Year
Category: Health News
Created: 12/21/2016 12:00:00 AM
Last Editorial Review: 12/21/2016 12:00:00 AM
Published Studies Related to Sublimaze (Fentanyl)
Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses
determined from oral morphine rescue doses in the treatment of breakthrough
cancer pain. 
evaluate the efficacy and safety of sublingual fentanyl tablet... CONCLUSIONS: Patients treated with strong opioid analgesics at fixed intervals
Effect of intravenous fentanyl given prior to the end of surgery on emergence
agitation in pediatric patients. 
CONCLUSION: Administration of intravenous fentanyl 1 microg/kg 15 minutes prior
Desflurane/fentanyl compared with sevoflurane/fentanyl on awakening and quality
of recovery in outpatient surgery using a laryngeal mask airway: a randomized,
double-blinded controlled trial. 
anesthetic regimen inclusive of opioids... CONCLUSIONS: Desflurane retains faster awakening properties than does sevoflurane
Clinical effects of intrathecal fentanyl on shoulder tip pain in laparoscopic
total extraperitoneal inguinal hernia repair under spinal anaesthesia: a
double-blind, prospective, randomized controlled trial. 
anaesthesia... CONCLUSIONS: Addition of intrathecal fentanyl to local anaesthetic can relieve
A double-blinded randomized evaluation of alfentanil and morphine vs fentanyl:
analgesia and sleep trial (DREAMFAST). 
interference... CONCLUSIONS: Despite better early postoperative analgesia, pain-related sleep
Clinical Trials Related to Sublimaze (Fentanyl)
Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain [Recruiting]
This study will investigate the influence of intra-operative use of remifentanil versus
fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via
sternotomy. Secondary quantitative sensory testing is performed to determine thermal and
electrical detection and pain threshold and the difference in pain variability scoring.
Postoperative pain scores, analgesic use, genetic variances and costs are measured.
Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients [Recruiting]
Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the
patient. The pain associated with the procedure is not caused by the insertion of the scope
but from inflating of the colon in order to do the inspection. It has been shown that
colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients
feel discomfort during the procedure. Factors predicting a painful colonoscopy are
female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy
(Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are
associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or
analgesia are achieved by administering a benzodiazepine or a combination of a
benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine
(Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol
as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of
colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most
commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely
increases the cost of procedure; drug administration, need for pulse oximetry monitoring and
the need for follow-up after the procedure make colonoscopy sometimes expensive and
troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor
makes patients forget it (Elphick et al. 2009).
Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal
sublingual formulation of fentanyl has been developed to further improve the management of
pain. When administered as a sublingual fast-dissolving tablet (AbstralÂ®) that is placed
under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by
the body through the mucous membrane. After administration of buccal fentanyl maximum plasma
drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl
concentrations versus time following buccal and sublingual administration are very similar
(Darwish et al. 2008). AbstralÂ® sublingual tablets should be administered directly under
the tongue at the deepest part. Sublingual administration is an easy and non-invasive
method of pain treatment for the patient coming to colonoscopy done as an office based
procedure. Other advantages compared to invasive methods are improved comfort of patients
and no need for intravenous access because of pain relief. Before, it has been used in the
management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be
effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al.
2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.
Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia [Recruiting]
Hypotension is frequently encountered after induction of general anesthesia. It can be
pronounced in elderly patients and can require administration of vasopressor agents
including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged
episodes, can contribute to an increase in morbidity and mortality in the postoperative
period as suggested by some former studies. The investigators hypothesize that fentanyl can
contribute to the decrease in blood pressure (BP) that is seen after induction of general
anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the
sympathetic nervous system.
This study will be the first one to examine the effect of fentanyl administration on blood
pressure in elderly patients with induction of general anesthesia prior to the start of
surgery. If the study shows that fentanyl contributes to hypotension during this period, it
may lead to a change in practice and better patient outcomes and mortality rates.
Breakthrough Dyspnea Fentanyl Study in Cancer Patients [Completed]
The goal of this clinical research study is to learn if fentanyl given under the skin can
reduce shortness of breath in cancer patients. Researchers also want to learn if it can
help to improve your physical function. In this study, fentanyl will be compared to a
Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients
with their shortness of breath as well.
A placebo is not a drug. It looks like the study drug but is not designed to treat any
disease or illness. It is designed to be compared with a study drug to learn if the study
drug has any real effect.
Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain [Recruiting]
Epidural analgesia has proven to be an effective method for severe pain relief associated
with labor and delivery. During labor, a low dose continuous infusion of local anesthetic
and narcotic will be administered through an epidural catheter. As labor progresses and the
baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs
further treatment. The investigators provide pain relief by administering analgesics through
the epidural catheter.
The patient will be randomly assigned to receive one of two medication mixtures believed to
be successful in treating this type of pain associated with advanced labor. After this
initial treatment, if pain relief is not attained, the patient may receive the other
medication as well. The medications used in this study have been used at this institution
for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose
is small and only a small fraction will be transmitted to the baby. The other medication
(clonidine) better known as a blood pressure medication has also been used for pain relief.
Studies and clinical experience have shown that clonidine when given epidurally in the doses
used in this study has minimal if any effect on the blood pressure of the mother or of the
baby. The investigators will record medical and obstetric history and labor progress
relevant to the patient. The patient will be asked questions regarding labor pain and side
effects before and after the analgesic is administered.
The primary objective is to determine which treatment regimen is more successful in
abolishing breakthrough pain in advanced labor.